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Study identifier: NCT06370689 Synced from ClinicalTrials.gov · July 29, 2026
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Comparison of Three Pre-oxygenation Strategies

Condition: Emergencies · Anesthesia  ·  Sponsor: Institute of Mountain Emergency Medicine

PhaseNA
Planned participants45
Who can joinAll sexes, 6 Years to no upper limit
Healthy volunteersYes

About this study

Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers. Study endpoints Primary Endpoint: Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions. Secondary endpoints: * Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions. * Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT) * Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5 * Time to reaching an Oxygen Reserve Index (ORi) =1 * Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions. Number of participants 15 participants per subgroup, i.e. 45 participants in total. Inclusion criteria * Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II * Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3 * Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day. After informed consent and a medical check-up, baseline measurements will …

This description comes directly from the study's public registry record.

Talk to the study team

Simon Rauch, MD, PhD  ·  00393404967398  ·  simon.rauch@eurac.edu

Giulia Roveri, MD  ·  giulia.roveri@eurac.edu

Always discuss trial participation with your own doctor first.

Locations (1)

TerraXCubeBolzano, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06370689